Regulatory: Page 84

Regulatory
Rare Disease Research Project Hopes to Help Product Development
Grants are being offered to learn how specific rare diseases progress in individuals over time.
March 1, 2016
Pharmaceuticals
FDA and Pharma to Collaborate on Manufacturing Tech Program
The latest draft guidance invites drug makers to work with the agency’s new Emerging Technology Team to implement modern technologies that will improve processes and increase Quality by Design.
February 29, 2016
FDA and Pharma to Collaborate on Manufacturing Tech Program
Materials
Propeller, Aptar Partner for Next-Generation Metered Dose Inhaler
Partnership to develop the first digital, connected metered dose inhaler (cMDI) available for the global respiratory pharmaceutical market.
February 26, 2016
Propeller, Aptar digital cMDI.
Packaging/Filling
NJM Packaging: Aseptic Fill/Finish With Isolator
Dara aseptic fill-and-finish system combines with Getinge La Calhene’s isolator technology in cleanroom environment.
February 26, 2016
NJM Packaging: Aseptic Fill/Finish With Isolator
Regulatory
FDA Issues Statement on Califf’s Senate Confirmation
Agency applauds the U.S. Senate’s vote to support the confirmation of Dr. Robert Califf, M.D. as FDA Commissioner.
February 25, 2016
Dr. Robert Califf, M.D. (Photo from FDA)
Robotics/Automation
Siemens, ADENTS Partner To Address Serialization
Siemens’ global technology and Adents’ software provide drug manufacturers with item-level serialization capabilities at a competitive price.
February 25, 2016
Regulatory
FDA Fully Confident in Indian Pharmaceutical Inspectors
The agency is working with the Indian government to ensure medical products manufactured there meet FDA requirements.
February 24, 2016
Robotics/Automation
The New Pharma Factory
Under FDA and industry pressure, drug manufacturers are abandoning their old batch ways for a continuous approach to manufacturing. But it’s a slow transition.
February 24, 2016
Pfizer's PCCM manufacturing prototype.
Supply Chain
Improving Site Efficiency Reported as Primary Contract Packaging Goal
Contract packagers/manufacturers and third-party logistics providers also identify quality control and compliance as key challenges in Nulogy survey.
February 24, 2016
Nulogy's PackManager in a production environment.
Regulatory
FDA Turns to China During Chemo Drug Crisis
Banned Chinese drugmaker allowed to ship API to help with shortage.
February 23, 2016
Regulatory
Hackers Try to Access FDA Data
Report shows from January 2013 to June 2015, the FDA received 1,036 security incidents.
February 23, 2016
Materials
Marchesini Group and Abbott Hold Health Innovation and Italian Manufacturing Event
The machinery manufacturer and Abbott joined forces in a unique pharma and packaging partnership to produce a novel med device for diabetic monitoring.
February 23, 2016
Speakers at Merchesini-Abbott event.
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Top Stories
Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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